INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
FDA 510(k) clearance K132620 · decided 2014-04-16
Clearance details
- K-number
- K132620
- Device name
- INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
- Applicant
- Pan Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-21
- Decision date
- 2014-04-16
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gloucester, Gloucestershire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.